We propose to develop a highly sensitive and rapid point-of-care nucleic acid test based on IQuum's lab-in-a-tube (Liat") platform for the quantification of Human Immunodeficiency Virus (HIV-1) from plasma samples. The Liat HIV Assay will utilize the Liat Analyzer to enable the minimally trained personnel to perform the HIV-1 test at a hospital, clinic or physician's office in less than 1 hour. By enabling effective and sensitive single visit HIV-1 quantitative testing, we expect that the Liat assay will allow clinicians to rapidly change a patient's antiretroviral therapy once a significant change in viral load has been identified. The Liat HIV-1 Assay overcomes the limitations of current HIV-1 tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for rapid therapy changes disease prevention due to turn around times and patient follow-up. In Phase II, we propose to expand the assay developed from Phase I by integrating all assay components, including the internal quantitative controls, into a single Liat tube for multiplex HIV-1 quantification. In addition, a semi-automated manufacturing solution for Liat HIV-1 Assay Tube production will be developed and validated. Finally, the Liat HIV-1 Quantitative Assay will be characterized and validated in analytical and pre-clinical studies. At the conclusion of this phase of the project, we will be prepared to initiate external clinical studies in support of a PMA submittal to the Food and Drug Administration (FDA). The assay will be among the first point-of-care nucleic acid tests, and will provide significant benefit to public health. PUBLIC HEALTH RELEVANCE: By enabling effective and sensitive single visit HIV-1 quantitative testing, the Liat" HIV-1 Quantitative Assay will allow clinicians to quickly identify treatment failure and provide immediate and effective intervention, thereby significantly improving the quality of life for HIV-1 infected persons. The Liat HIV-1 Quantitative Assay overcomes the limitations of current HIV-1 tests, whose long turnaround time and technical complexity requires testing to be performed in centralized laboratories, resulting in missed opportunities for disease intervention due to maintaining patients for extended times on ineffective treatment regimens. The assay will also be among the first point-of-care nucleic acid tests, and will provide significant benefit to patient health and welfare.